2024 DMEPOS Series #7: Therapeutic Shoes for Diabetics

Many pharmacies struggle with DMEPOS audits due to the complexity in medical billing and the onerous documentation requirements. Medicare Part B suppliers need to be able to produce all the required documentation if audited, and make sure all documentation meets Medicare Part B standards. This DMEPOS series is intended to help you understand these complexities and gather the needed documents.

Specifically, you need to demonstrate the following in case of an audit regarding therapeutic shoes for diabetics:

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  • Standard Written Order (SWO)
  • Signed and dated Certifying Physician Statement specifying the beneficiary meets all the following:
    • Certifying Physician is an M.D. (Medical Doctor) or D.O. (Doctor of Osteopathy)
    • Has diabetes
    • Has one of the following conditions:
      • Previous amputation of the other foot, or part of either foot, or
      • History of previous foot ulceration of either foot, or
      • History of pre-ulcerative calluses of either foot, or
      • Peripheral neuropathy with evidence of callus formation of either foot, or
      • Foot deformity of either foot, or
      • Poor circulation in either foot
    • Is being treated under a comprehensive plan of care for his/her diabetes, and needs diabetic shoes
    • The certification statement was signed on or after the date of the in-person visit and within 3 months prior to delivery of the shoes/inserts
  • Medical Records
    • Evaluation was performed by the Certifying Physician, or entity meeting the “Incident to” requirements or a Nurse Practitioner (NP) enrolled in Primary Care First (PCF)
    • Evaluation was performed and/or reviewed by the Certifying Physician prior to completion of the Statement of Certifying Physician
    • Visit to document the qualifying foot condition occurred within 6 months prior to delivery
  • Supplier Evaluation documenting that the beneficiary has one or more of the qualifying conditions listed above
    • An examination of the beneficiary’s feet with a description of the abnormalities that will need to be accommodated by the shoes/inserts/modifications
    • Measurements of the beneficiary’s feet
    • For custom molded shoes and inserts, information regarding taking impressions, making casts, or obtaining CAD-CAM images of the beneficiary’s feet that will be used in creating positive models of the feet
  • Supplier Assessment of Fit
    • Must occur at the time of in-person delivery
    • Supplier must conduct an objective assessment of the fit of the shoes and inserts while the beneficiary is wearing them and document the results
      • For Example: no slippage of heals when walking, ample toe room, feet are supported by heel counter, inserts make contact with patient’s feet and fit inside the shoe properly
    • A beneficiary’s subjective statement regarding the fit does not meet this criterion as they may have neuropathy which prevents them from feeling if there is any rubbing or pinching
  • Proof of Delivery

PAAS Tips:

  • A new Certification Statement is required for a shoe, insert or modification provided more than one year from the most recent Certification Statement on file
  • A new order is not required for the replacement of an insert or modification within one year of the order on file. However, the supplier’s records should document the reason for the replacement
  • A new order is required for the replacement of any shoe
  • Review documentation checklist for Jurisdiction A and D
  • Review documentation checklist for Jurisdiction B and C
  • Review the Therapeutic Shoes for Person with Diabetes LCD
  • Review the following Newsline articles for additional information:

Search the Newsline archive for keyword “DMEPOS series” to read previous articles in this series. If you have any questions on accessing the Member Portal, or need help adding employees so they have access, please contact us and our staff can assist you.

Jenevra Azzopardi, CPhT